Here learn about the complete process of Auto Coater Installation Qualification along with Annexures, criteria, approval, final report, and conclusion.

ITEM DESCRIPTION

PROTOCOL APPROVAL

OVERVIEW:

Objective

Purpose

Scope

Responsibility

Execution Team

ACCEPTANCE CRITERIA

REVALIDATION

INSTALLATION QUALIFICATION PROCEDURE

System Description

Instruction for Filling the Checklist

Installation Check-List

Identification of Major Components

Verification of material of construction

Identification of Supporting Utilities.

Identification of Safety Feature(s)

Identification of Standard Operating Procedure

Test instrument details

Identification of Component to be Calibrated

Verification of Drawings and Documents

Abbreviations

Deficiency And Corrective Action(s) Report(s)

Annexure(s)

INSTALLATION QUALIFICATION FINAL REPORT

Summary

Conclusion

Final report approval

1.0	PROTOCOL APPROVAL:

The signing of this approval page of the Protocol indicates agreement with the qualification approach described in this document. If a modification to the qualification approach becomes necessary, an addendum shall be prepared and approved. The protocol cannot be used for execution unless approved by the following authorities.

This Installation Qualification protocol of Auto Coater has been reviewed and approved by the following persons:

FUNCTION	NAME	DEPARTMENT	SIGNATURE	DATE
PREPARED BY		QUALITY ASSURANCE
REVIEWED BY		PROJECTS / ENGINEERING
REVIEWED BY		PRODUCTION
APPROVED BY		QUALITY ASSURANCE

2.0

OVERVIEW:

2.1	OBJECTIVE:
	The objective of developing and executing this protocol is to collect sufficient data about the Auto Coater and define the installation qualification requirements and acceptance criteria for the Auto Coater. Successful completion of these installation qualification requirements will ensure that the Auto Coater was installed as required in the manufacturing area.
2.2	PURPOSE:
	The purpose of this protocol is to establish documentary evidence to ensure that the Auto Coater system received matches the Design specification and also to ensure that it is properly and safely installed.
2.3	SCOPE:
	This Protocol applies to the installation of Auto Coater at the tablet manufacturing facility at (Company Name) & the subsequent documentation.
2.4	RESPONSIBILITY:
	The following shall be responsible: Quality Assurance officer/ Executive – Preparation of protocol projects / Engineering Head – For execution Production Head – For execution support Quality Assurance Head – For adequacy and final approval

2.5	EXECUTION TEAM:
	The satisfactory installation of the (Company Name) Auto Coater shall be verified by executing the qualification studies described in this protocol. The successfully executed protocol documents that the Auto Coater is installed satisfactorily. The execution team is responsible for the execution installation of Auto Coater Execution team comprises of:

DEPARTMENT	DESIGNATION	NAME	SIGNATURE	DATE
PROJECTS/ ENGINEERING
PRODUCTION
QUALITY ASSURANCE

3.0	ACCEPTANCE CRITERIA:
3.1	The Auto Coater shall meet the system description given in the design qualification.
3.2	The Auto Coater shall meet the acceptance criteria mentioned under the topic “Identification of major components”
3.3	The Auto Coater system shall be operated by PLC.

4.0	REVALIDATION CRITERIA:
	The Auto Coater has to be revalidated if…
	Any major changes in system components affect the performance of the system· After a major breakdown maintenance is carried out. As per the revalidation date and schedule.

5.0	INSTALLATION QUALIFICATION PROCEDURE:

5.1

AUTO COATER (Version Name) SYSTEM DESCRIPTION:

Process Equipment Description

The purpose of (Company Name) Auto Coating Machine (Version Name) is to coat tablets of all common sizes and shapes whether it is for film or aqueous coating. The hot air in this equipment will enable a very efficient heat and mass transfer. The hot air flow is controlled by PLC and is programmable to accommodate various types of tablets and their coating materials.

The complete machine can be divided into the following sub-sections:

• Inlet System
• Pan
• Spray System
• PLC System
• Cleaning system
• Exhaust System
• Control System

Inlet System: It consists of pre & medium air filters, HEPA filters (Optional), air heating unit, and airflow & temperature measuring devices. The inlet air handling unit (Inverter control) receives air from the environment and processes the inlet air and controls the inlet airflow.

Pan: It consists of the semi-perforated fully enclosed pan which contains 8 ducts that engage with the incoming air and the outgoing air through arc shaped inlet duct from the heat exchanger and outlet duct that goes to the exhaust. At any point in time, two circular cross-sectional areas of the pan engage with the hot air inlet and outlet.

Spray System. It consists of a peristaltic pump in case of film coating. This pump is selected based on the viscosity of the solution that has to be coated. This pump is eventually connected to the tubing that leads to high-pressure low-volume guns. The angle of the spray and the flow rate are externally controllable.

A programmable logic controller (PLC) will execute the direction of the sequence of operations. The PLC of (Brand Name) (or equivalent) is used for this purpose.

5.2 PLC Description

The main function of a PLC is to translate the instructions into the digital or analog codes needed to operate the device or machine.

PLC collects data from field instrumentation & displays the information on the operator station. The instruments are connected to the system equipment and piping. The PLC will utilize the collected data for process control.

The user interface, based on an industrial-type HMI, will assist the operator to supervise and control the process. Based on the displayed information the operator, using the user interface, can provide commands to the PLC.

The PLC then executes the operator’s instructions. A (Brand Name) has been chosen as the Central Processing Unit (CPU). There are six inner boards available, which are mounted in Slot 1 or Slot 2 of a (Serial Number). The protocols are made on the XYZ – Protocol Support Software and then recorded in the Serial Communication Board, where they can be executed at any time using the PMCR instruction in the CPU unit’s ladder diagram.

The PLC system layout for the coating machine automation is as shown below: 

5.2	INSTRUCTION FOR FILLING THE CHECKLIST
5.2.1	In case of compliance with the test use the word ‘Complies’ otherwise use ‘Does not comply‘ to indicate non-compliance.
5.2.2	For identification of the components of the equipment and utilities use the word ‘’yes’’ to show its presence and use ‘No’ to indicate the absence of the identity
5.2.3	Give detailed information in the summary and conclusion part of the Installation Qualification report.
5.2.4	Whichever column is blank or not used ‘NA’ shall be used.

5.3	INSTALLATION CHECKLIST:
	The installation checklist is as follows:

Sr.NO.	STATEMENT	YES / NO	CHECKED BY(SIGN)	DATE
	Verify that the “As Built” drawing is complete and represents the design concept.
	Verify that major components are securely anchored and shockproof.
	Verify that there is no observable physical damage.
	Verify that there is sufficient room provided for servicing.
	Verify that all piping and electrical connections are done according to the drawings.
	All access ports are examined and cleared of any debris.
	Safe electrical connections.
	Sufficient room is provided for maintenance.
	The equipment identification nameplate is visible.
	Units installed on the foundation are secure as per the manufacturer’s recommendations.

5.4	IDENTIFICATION OF MAJOR COMPONENTS:
	Describe each critical component and check them and fill out the inspection checklist.

System Components	Design Specification		Complies / Does Not Comply	Checked By(Sign)	Date
1. Equipment Description	Model	XYZ
	Output Capacity	120 – 150 Kg (Put Value)
	Power of the Main motor	3.7KW (Put Value)
	Hot water Pressure	3 Kg/cm sq.
	Volume of Heating	42000 KCal (Put Value)
2. Pan	Pan diameter	1300mm (Put Value)
	Material	SS 316L
	Spray Sliding Cylinder	SS 304
	Rabbit Ear Baffles	7 Nos. (Put Value)
	Pan Motor	3 HP (Put Value)
	Pan speed	1 – 12 RPM (Put Value)
3. Solution Tank	Capacity	100 L (Put Value)
	Material of construction	SS316L
	Manufacturing Design	Casters mounted.
4. Air Device Rating	Main Air Regulator	0~10 Kg/cm sq.
	Atom Air Regulator	0~10 Kg/cm sq.
	Spray Gun Air Regulator	0~10 Kg/cm sq.
	Air Pump Regulator	0~10 Kg/cm sq.
	Main Pressure Gauge	0~10 Kg/cm sq.
	Air Flow Meter	0~500 Lit/min.
	Manometer	0~500 mm Aq
5.  Pump	Manufacturer	XYZ
	Model	Modal Name
	RPM	Max 220 (Put Value)
	Shaft Torque	2.2 Nm
6. Other Components	Touch Screen	XYZ
	Proximity switches	Autonics Corporation
	Flowmeter	XYZ
	Magnehelic Differential pressure gauge	XYZ
	Solenoid Valve	TPC Pneumatics
	VFD	XYZ
7. Spray Gun	Manufacturer	XYZ
	Model	Modal Name
8. Exhaust Blower Air Fan Motor	Manufacturer	XYZ
	Speed Controller	XYZ VFC
	Filter	Polyester filter bag with an auto-shaking function
9. Operating Control Panel	PLC Make	XYZ
	PLC Model	XYZ
	PLC CPU	CPU 44 (Put Value)

5.5	Verification of Material of construction:

Sr. No.	Name of components	Material of construction	Method of verification	Verified by(Sign & Date)
1	Rotary Inlet Outlet Valve	SS 41
2	Outside Door	SS304
3	Outside Cover	SS304
4	Pan Door	SS316 & Strengthened Glass
5	Auto damper	SS304
6	Coating Pan	SS316
7	Film Tank	SS 316
8	Coating Door	SS 304
9	Machine Body	Frame: SS41, Cover: SS 304
10	Liquid Tank Flange	SS304
11	Tank Top Cover	SS304
12	Liquid Tank	SS316
13	Liquid Tank Oil Seal Cover	SS304
14	Liquid Tank Impeller shaft coupling	SS304

5.6	IDENTIFICATION OF SUPPORTING UTILITIES:

UTILITY	PROPERLY IDENTIFIED & CONNECTED (YES/NO)	CHECKED BY (SIGN)	DATE
1) Electricity: 3 Phase, 415Volts, 50Hz
2) Compressed air: 6 kg/cm2                                                                      12 mm, 500 L/min
3) Hot water 65000Kcal/Hr, 2Kg/cm2

5.7		IDENTIFICATION OF SAFETY FEATURES:
		Identify and record the safety features (if any) and their function in the following tables:
Safety Features Description					Function	Identified By(Sign)	Date
Earthing					To avoid electrical shocks due to leakage current.
Alarm Message
1. Purging Air Pressure Low					If the air pressure drops below the minimum set level, then this alarm will trip the machine.	.
2. Machine Stoppage					If the emergency stop is operated the alarm will generate
3. Main Motor Overload					If the Sharft motor is overloaded the alarm will generate and trip the process

5.8			IDENTIFICATION OF STANDARD OPERATING PROCEDURE (SOP)
The following Standard Operating Procedures were identified as important for the effective performance of Auto Coater
1		Operation and cleaning of Auto Coater
2		Preventive maintenance of Auto Coater

5.9	TEST INSTRUMENT DETAILS
	Instrument/Equipment required: 1. Tacho Meter 2. Anemometer 3. Temperature sensor 4.Pressure Gauge 5. Photometer

5.10	IDENTIFICATION OF COMPONENT TO BE CALIBRATED
In the Auto Coater, the following are the components, which need calibration. The following are the components:  1. Pressure Measurement (Purging Air)  2. Temperature Measurement 3. R.P.M.

5.11	VERIFICATION OF DRAWING AND DOCUMENTS:
	The following documents are reviewed and attached below: (Fill Your Details Below)

Sr. No.	DRAWING AND DOCUMENT DETAIL	CHECKED BY (SIGN)	DATE

5.12	ABBREVIATIONS
	The following Abbreviations are used in the installation qualification protocol of the Air handling unit
	MOC: Material of construction RPM: Rotation per minute Nm: Neuton meter PLC: Programming Logic Controller ACT: Auto Coater

5.13	DEFICIENCY AND CORRECTIVE ACTION (S) REPORT (S)
The following deficiency was identified and corrective actions were taken in consultation with the validation team.

Description of deficiency:

Corrective action(s) taken:

Reviewed By:

Date

5.14 Annexure(s):

Sr. No.	Annexure No.	Title of Annexure

6.0	INSTALLATION QUALIFICATION FINAL REPORT:

All the IQ data sheets and discrepancy reports shall be reviewed by the validation team to prepare a summary report. The summary of IQ shall be used to conclude approval of the installation qualification report.

6.1	SUMMARY
6.2	CONCLUSION

6.3 FINAL REPORT APPROVAL

It has been verified that all tests required by this protocol are completed, reconciled, and attached to this protocol or included in the qualification summary report. Verified that all amendments and discrepancies are documented, approved, and attached to this protocol.

The signature in the block below indicates that all items in this qualification report of Auto Coater (Modal) have been reviewed and found to be acceptable and that all variations or discrepancies have been satisfactorily resolved.

NAME	DESIGNATION	DEPARTMENT	SIGNATURE	DATE
		PROJECTS / ENGINEERING
		PRODUCTION
		QUALITY ASSURANCE

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